Critics, the US presidential election and a lawsuit are putting the reclassification of laboratory-developed tests (LDT) as ...

The US Food and Drug Administration (FDA) has issued its Final Rule in officially making explicit that In Vitro diagnostic products (IVD), also known as laboratory-developed tests (LDT), are ...

The FDA’s Webinar for Manufacturers and Other Interested Parties - The U.S. Food and Drug Administration (FDA) will host a webinar ...

Meanwhile, in an executive order, Trump created his long-discussed “Department of Government Efficiency,” to be led by Elon ...

2024 –The Food and Drug Administration’s (FDA) final rule has reclassified laboratory developed tests (LDTs) as medical devices, according to Avalere. The rule leads to a paradigm shift that ...

Opens in a new tab or window As the new Congress and a new administration start up, the fate of FDA-issued regulations on laboratory-developed tests (LDTs) is one of many issues that health ...

Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and ...

The problem ingredient identified was "undeclared milk," which poses a risk to those with severe sensitivities or allergies.

The Scotland-based firm said that it will use the money for the development of its cancer tests and commercialization in new markets.